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V Vol. 12 No. 1 RESEARCH IEW Innovation & Scholarship at The University of Montana WINTER 2010 From Mice to Men Damage-reducing stroke drug moving to human trials U niversity of Montana researchers have learned that low doses of methamphetamine given to rodents after strokes reduce brain damage and impairment by 50 percent or more. Now a UM research spinoff company, Sinapis Pharma, intends to start human Phase I clinical trials of the drug application in coming months. “We have had fabulous results with rodent models,” says David Poulsen, a research associate professor in UM’s Department of Biomedical and Pharmaceutical Sciences and chief scientific officer for the new company. “If we have comparable results with people, this could become the standard of care.” On the street, meth is a dangerous, addictive and illegal drug. However, the Food and Drug Administration first approved prescription methamphetamine for clinical uses in 1944, and now it is used to treat attention deficit hyperactivity disorder, obesity and narcolepsy. Poulsen and his postdoctoral student Tom Rau have since discovered the protective effect of low-dose meth for strokes. “The drug already has been approved for treating ADHD in children and obesity in adults as an oral dose,” Poulsen says. “What we are doing is giving the drug in David Poulsen, a scientist in UM’s College of Health Professions and Biomedical Sciences, poses with images of sliced rat brains. The top row was treated with methamphetamine six hours after a stroke, while the bottom row received saline. White areas reveal dead or damaged tissue. an IV form, so this is a new formulation that’s being administered for a new application – stroke. This has never been done before.” Sinapis Pharma will file an Investigational New Drug application with the FDA in February, and Poulsen expects Phase I trials to begin shortly thereafter and be completed by summer. During the trials, researchers test the new drug on a small group of people (20 to 80) to evaluate its safety, determine dosage and identify side effects. “Basically we give them the drug in an IV and draw blood from them every couple of hours and monitor their blood pressure and heart rate and such,” Poulsen says. He expects the Phase I trials to go smoothly because methamphetamine has been around a long time, and there is a lot of documentation about what humans can and can’t handle. “We don’t have to deal with a lot of the steps and hurdles encountered with the development of a new drug,” he says. If Phase I goes well, the process will move to Phase II, when patients experiencing strokes at hospitals will be asked to give informed consent to test the drug. “Some people will say no, and some will say yes, and some won’t meet the criteria,” Poulsen says. “We are talking about hundreds of patients for this kind of trial, so we would do it at large metropolitan areas across the United States, but I would like St. Patrick Hospital (and Health Sciences Center in Missoula) to be one of the places we recruit patients. I know I would want the drug if I was having a stroke.” The researcher hopes to start Phase II trials by the end of the year. About 60 different drugs have been tested as neuroprotective agents over the years, and they all have failed. Poulsen says this is because a cascade of pathological events occurs during a stroke, and most of those drugs target only one event, which is insufficient to tip the balance to protection. Stroke — continued back page

Research View -- Winter 2010

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